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Completed

NCT Number: NCT01244581

Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry

The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating acute otitis media in children. The primary end point is time to disappearance of middle ear effusion which monitored by daily tympanometry performed by families and study physicians.

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Key information

Conditions

Otitis Media, Suppurative Ear Diseases Infections Otitis Otitis Media Otitis Media with Effusion Otorhinolaryngologic Diseases Suppuration

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Pediatrics, Oulu University Hospital, Oulu, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with acute otitis media

Exclusion criteria

  • Amoxicillin allergy
  • Tympanic membrane perforation
  • Tympanostomy tubes (current)
  • Complication of acute otitis media such as mastoiditis

Treatment and study plan

amoxicillin-clavulanate

Drug

Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days

Other names: Clavurion

Placebo

Drug

Placebo mixture in two daily doses for 7 days

Primary outcomes

  1. Time (days) to disappearance of middle ear effusion

    Time frame: Within 60 days

    Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry.

Secondary outcomes

  1. Time (days) to disappearance of pain

    Time frame: Within 60 days

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

Oral Amoxicillin-clavulanate in Treating Acute Otitis Media in Children: Randomized Double-blind Placebo-controlled Study Including Daily Monitoring With Tympanometry

Important dates

Study start
1999
Primary completion
2012
Study completion
2012
First posted
Nov 19, 2010
Registry last updated
Jun 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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